On-Site Night QA Manager – Biotech

VetJobs; West Greenwich (RI); On-site; USD 118,000 - 160,000; Full time

Job summary

Amgen in West Greenwich, Rhode Island is seeking a Manager QA - Nights to lead, train, and develop Quality Assurance professionals in GMP manufacturing, and to manage change effectively while maintaining compliance on the night shift. You will oversee QA operations, approve procedures and change controls, lead investigations and audits, and partner with management to resolve issues and drive improvements.

The role offers a comprehensive benefits package and a competitive salary in the posted

Qualifications

• High School/GED and 12 years of Quality or Manufacturing experience OR
• Associate’s degree and 10 years of Quality or Manufacturing experience OR
• Bachelor’s degree or 5 years of Quality or Manufacturing experience OR
• Master’s degree and 3 years of Quality or Manufacturing experience OR
• Doctorate degree
• Experience directly managing people and leadership roles in manufacturing or QA environments
• Experience in biotech/pharma manufacturing settings and regulatory contexts

Responsibilities

• Lead, train, and develop QA professionals on the night shift
• Oversee daily QA operations and ensure compliance with GMP
• Approve manufacturing and process validation documents
• Lead investigations and plant/site audits
• Coordinate cross-functional collaboration for CAPA and change control
• Provide guidance on procedures, standards, and risk management
• Represent QA on incident triage and project teams
• Drive continuous improvement and operational excellence

Skills

Quality Assurance

People management

GMP manufacturing

CAPA

Change control

Investigations

Regulatory compliance

Biotech manufacturing

Education

Bachelor's/Life Sciences/Engineering related

Job description

Amgen in West Greenwich, Rhode Island is seeking a Manager QA - Nights to lead, train, and develop Quality Assurance professionals in GMP manufacturing, and to manage change effectively while maintaining compliance on the night shift. You will oversee QA operations, approve procedures and change controls, lead investigations and audits, and partner with management to resolve issues and drive improvements.

The role offers a comprehensive benefits package and a competitive salary in the posted